In January 2020, a new reformulated version of Cystoprotek was released by Mylan Pharmaceuticals to remove the food coloring titanium dioxide which had generated a Prop 65 cancer warning. This is now removed and all issues have been addressed. CystoProtek is now available for purchase in the ICN Shop!
In May 2019, our order of CystoProtek® came with an unwelcome surprise, a new cancer warning on the bottle. Required by Proposition 65, a California based law that requires that any product or ingredient associated with cancer be clearly labelled, the CystoProtek® bottle now says “Warning: Cancer & Reproductive Harm (Prop. 65).” After a week long delay, the manufacturer Mylan Consumer Health has confirmed through their distributor (Emerson Healthcare) that one ingredient, titanium dioxide, triggered this warning.
When airborne, titanium dioxide, has been linked to the development of lung cancer.(1) However, it is approved by the FDA for use as a food coloring.(2) You’ll find it in toothpaste, candy and other products that need a white color. Unfortunately, there are also concerns about titanium dioxide nanoparticles. Due to their remarkably small size, some believe that nanoparticles may more easily enter the blood stream and spread throughout the body. Studies have found wide ranging adverse events, genetic aberrations and cell damage/death.(3,4) The developer of CystoProtek®, Dr. Theoharis Theoharides, encouraged Mylan to replace this ingredient some time ago.(5)
If you have found CystoProtek® to be helpful or receive automatic shipments from us, I’m sure that you are as concerned as I am. We DO have CystoProtek® in stock but we feel that you must be fully informed about this new warning. While this is the same product that has been for sale for many years and while the FDA has approved titanium dioxide for use, this raises concerns that only you and your doctor can decide. You can order it by phone (800-928.7496) or on our store website. We cannot sell it through Amazon because we were not provided new copies of the label. Amazon requires up to date images.
Watch Our Video Discussing This
Frequently Asked Questions
Are there other supplements that do not contain titanium dioxide and/or do not have a similar warning?
Yes. You can easily transition to other products, including:
- Bladder Rest™ – Natural Approach Nutrition (NAN) has created Bladder Rest™ as a reliable, viable substitute for CystoProtek but without any questionable ingredients. One ingredient, glucosamine, was removed due to lack of efficacy. They have also added L-Arginine & L-Citrulline, amino acids that reduce inflammation. Rather than using olive kernel oil which makes CystoProtek so heat intolerant and difficult to ship in the summer months, Bladder Rest™ uses powdered avocado oil which is much more heat stable. It will be much more affordable at approximately $39 a bottle.
- PEAORA™ focuses on relieving pain and discomfort using palmitoethylamide (PEA). This very affordable supplement (under $30) can be taken alone or combined with other supplements to reduce discomfort. This will also be in stock in early June 2019.
- BLADDER BUILDER™ was released in May 2019 and is a cutting edge approach to bladder health. It contains most of the key ingredients of CystoProtek but with some new ingredients that focus on improving body health including a few essential vitamins, collagen, amino acids, probiotics and palmitoethylamide (PEA) to reduce pain and discomfort. It is currently available for sale in the ICN Shop.
- Cysto Renew™
- The full Desert Harvest Aloe™ Product Line
Which product is closest to CystoProtek®?
Is CystoProtek® Discontinued or has it been recalled?
CystoProtek has not been recalled. That said, we will not be promoting CystoProtek for the foreseeable future. We will maintain a small quantity in our shop for those who feel that it’s their only option but we strongly encourage patients to try one of the other products that don’t have this warning.
Is Mylan Taking Steps To Reformulate CystoProtek®?
Mylan was apparently warned of this issue some time ago by Dr. Theoharides and Algonot. We have no idea if they intend to reformulate this product. They have issued no public statement sharing their plans.
If you have any questions, thoughts or concerns about the CystoProtek® issue, please don’t hesitate to call me personally. I am more than happy to share any updates that I have. The health and safety of the IC community has always been a priority.
Jill H. Osborne MA
Founder – Interstitial Cystitis Network
www.ic-network.com – www.icnsales.com
800-928-7496 – toll free
707-538-9442 – direct
firstname.lastname@example.org – email
- Baan R. Carcinogenic Hazards from Inhaled Carbon Black, Titanium Dioxide, and Talc not Containing Asbestos or Asbestiform Fibers: Recent Evaluations by an IARC Monographs Working Group. Inhalation Toxicology. Volume 19, 2007.
- Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics and Medical Devices. US FDA 11/15/2017
- Ali SA. Assessment of titanium dioxide nanoparticles toxicity via oral exposure in mice: effect of dose and particle size. Biomarkers 2019 May 28:1-7
- Gholinejad Z, et al. Titanium dioxide nanoparticles induce endothelial cell apoptosis via cell membrane oxidative damage and p38, P13K/Akt. MF-kB signaling pathways modulation. J Trace Elem Med Biol. 2019 Jul;54;27-35.
- Personal Correspondence